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NeuroSense Therapeutics to Present Crucial PrimeC Data at ALS Conference

On March 9, 2026, NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a biotechnology company in late-stage clinical development, is set to disclose vital long-term survival data from its Phase 2b PARADIGM trial focusing on PrimeC for amyotrophic lateral sclerosis (ALS). This presentation will take place during a leading scientific conference dedicated to ALS research.

Significance of the Findings

The recently reported survival analysis employs a Cox proportional hazards model, indicating a significant 65% reduction in mortality risk (hazard ratio 0.35; p=0.0037) after taking baseline risk factors into account. This evidence revealed a median survival advantage exceeding 14 months when comparing the PrimeC group (36.3 months) and the placebo group (21.4 months), with a log-rank p-value of 0.0218 as determined by Kaplan–Meier survival estimates.

Dr. Jinsy Andrews, who is a distinguished figure in ALS research and a member of NeuroSense's Scientific Advisory Board, will present the findings. She emphasizes that these survival outcomes from the Phase 2b randomized trial illustrate compelling evidence of a survival advantage for patients receiving PrimeC. The data validates the safety profile of PrimeC and its regulatory engagement as NeuroSense prepares for upcoming trials.

About the Clinical Trial

The PARADIGM Phase 2b trial was a double-blind, placebo-controlled study that involved 68 individuals diagnosed with ALS. Participants were randomly assigned to either receive PrimeC or a placebo over a six-month double-blind phase, followed by an open-label extension period. The baseline characteristics of both groups were comparable, ensuring that the findings can be viewed as indicative of PrimeC's effectiveness.

Earlier results from this trial reported significant slowing in the disease's progression, coupled with a favorable tolerability and safety profile noted over an 18-month treatment span.

Moving Forward

As NeuroSense charts its course for regulatory approval, the new long-term survival data bolsters the accumulated clinical dataset supporting PrimeC. This information helps set the stage for regulatory discussions and preparations for a Phase 3 study, which is a crucial step in transitioning from clinical research to marketing authorization.

NeuroSense remains proactive in discussions with regulatory authorities, striving to advance PrimeC towards potential market entry.

About NeuroSense

NeuroSense Therapeutics is dedicated to discovering and developing therapies for serious neurodegenerative diseases, such as ALS, Alzheimer's, and Parkinson's diseases. As it navigates the complex landscape of neurodegenerative disorders, NeuroSense’s approach combines therapies targeting multiple pathways linked to these diseases, addressing a critical unmet medical need.

The company firmly believes in the importance of innovative therapies in combating ALS, a disease that currently has no cure and typically leads to paralysis and death within a 2-5 year span from diagnosis.

About PrimeC

PrimeC, the leading drug candidate of NeuroSense, is an innovative oral formulation that merges two FDA-approved compounds: ciprofloxacin and celecoxib. This unique combination is tailored to address several mechanisms contributing to neuron degeneration, systemic inflammation, and irregular RNA regulation.

As ALS cases are projected to rise substantially by 2040, the stakes for breakthroughs in treatment have never been higher. NeuroSense's commitment is crucial as it seeks to bring solutions to those affected by these challenging diseases.

For further details and updates, interested parties can visit the NeuroSense website and follow the organization on LinkedIn, YouTube, and X.